FDA Approves First Digital Pill for Psychiatric Conditions

U.S. regulators have approved the first pill that contains a digital tracking sensor to alert doctors and caregivers as to whether a patient is taking a medication as scheduled.

The Food and Drug Administration (FDA) said in a statement that the digitally enhanced medication - called Abilify MyCite - "is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults".

"Patients can also permit their caregivers and physician to access the information through a web-based portal", the FDA noted - opening the possibility that others can track a patient's adherence (or lack thereof) to drug therapy. The patch is worn on the left rib cage and receives the signal from the sensor several minutes after the pill is ingested.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or not occur", a statement from the FDA said.

Applying technology directly into the medicines themselves is a more cutting-edge approach, but one that is clearly gaining traction, as evidenced by the FDA's approval of Abilify MyCite (aripiprazole tablets with sensor).

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, M.D., the director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a statement. This patch in turn sends signals to the patients' smartphone, telling them whether or not they've taken the pill, along with the pertinent dates and times.

Abilify MyCite's labeling information also notes the product's ability to improve treatment compliance in patients has not been proven. The sensor, which has no battery or antenna, is activated when it gets wet from the fluids in the stomach, according to Reuters. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients". By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER". "With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way".

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